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Regulatory Requirements for Early Phase Drug Product Development

Supporting a compound from discovery to clinical phases and potentially commercial phases requires an immense amount of time, energy, and money. Regulatory management is paramount during the drug development pipeline funnel, and recognizing Current Good Manufacturing Practices (cGMPs) is the foundation of drug safety and efficacy.

Every country has its own regulatory authority, responsible for enforcing rules and regulations and issuing guidelines for drug development, licensing, registration, manufacturing, marketing, and labeling of pharmaceutical products.[1]

Topics: Thought Leadership Regulatory Compliance Drug Product Preclinical Studies

Editorial: Designing a CMC Strategy for Accelerated Development of Biotherapeutics

Alcami recently contributed to a special feature in Drug Development and Delivery magazine titled "Designing a CMC Strategy for Accelerated Development of Biotherapeutics."

As the pipeline of biologic drugs intended to treat complex disease expands, the typical timeline for drug development seems to be shortening more frequently and with more intensity. There are many drivers to accelerate development.

Topics: Thought Leadership Regulatory Compliance Biologics Editorials CDMO Parenteral Manufacturing Cell and Gene Therapies

Editorial: Novel Therapies Roundtable Discussion

Alcami recently contributed to a roundtable discussion in Pharma's Almanac magazine, answering the question:

"What truly novel therapies in the earliest stages of discovery and development do you believe will have a significant impact in the future?" 

The article shares insights to this question from Alcami, along with other companies in the biologics space.

Topics: Thought Leadership Biologics Editorials Development

SCIENTIST SPOTLIGHT: May 2019

Name: Colleen Caffarelli
Alcami Site: Edison, NJ

How long have you been with Alcami?
I joined Alcami six years ago.

What is your role? 
I am a regulatory compliance specialist II. 

What is the most rewarding part of your job?
As part of my job, I host client audits. I love meeting with our clients and seeing how the work we perform impacts their company and ultimately the patients that rely on the medications produced. Client audits provide an opportunity to see different perspectives and facilitate continuous improvement.

Topics: Alcami Voices

Alcami Pays Tribute to Fallen Patriots this Memorial Day

Alcami joined the nation in remembering and honoring fallen members of the U.S. Armed Forces this Memorial Day with a donation to the Purple Heart Foundation and a strong public showing of support for longtime Alcami employee and Vietnam veteran, Herman Anthony.

In a special tribute to the brave men and women who sacrificed their lives in service to our country, Anthony was invited by the Milwaukee Brewers to participate in a May 26 ceremony on the Miller Park playing field during the national anthem.

Topics: Company News Alcami in Action

Alcami Exhibiting at BIO International Convention 2019

Alcami will be attending BIO International Convention, to be held June 3 - 6, 2019 in Philadelphia, PA.

Be sure to stop by Booth #3401 and connect with the Alcami team.

Schedule a Meeting

 

Topics: Events

Alcami Supports Homestead High School’s Varsity Robotics Club

Alcami continues to make science, technology, engineering, and mathematics (STEM) education and training initiatives a priority in 2019, this time partnering with Homestead High School in Mequon, Wisconsin, to support the school’s growing robotics club. The company has agreed to sponsor Homestead’s 2019 competitions and demonstrations, which will help its club purchase new computers and 3D printers. On average, teams invest approximately $4,000 to build a robot from the ground up and participate in competitions.

Topics: Company News Alcami in Action

Stability: Top Testing Factors You Should Consider

Stability testing is a fundamental part of the drug development process— upholding the quality of active pharmaceutical ingredients (APIs) and drug products while also providing an accurate shelf life. Through stability testing, pharmaceutical companies are able to determine the most suitable packaging and/or container closure system for the storage and distribution of drug products.

“Stability storage and testing plays a big part in the drug development process from research and development up to commercialization and beyond,” said Alcami Senior Manager of Stability Services, Scott Jedrey. “Testing throughout each phase, whether it is physical or chemical, allows data to be gathered, trended, and reviewed. Based on the data, decisions are made on whether to move forward to the next phase, which includes more testing and more patients in several clinical trials. The product must possess the purity, potency, and safety throughout each phase of the drug development process in order to obtain that very important agency approval.”

Topics: Stability Analytical Testing

Alcami and Students 2 Science Inspire Future Scientists

Students 2 Science (S2S) is a New Jersey-based nonprofit committed to inspiring and educating elementary, middle, and high school students to pursue careers in science, technology, engineering, and mathematics (STEM). Through strategic partnerships between businesses, institutions of higher education, district leadership, and workforce-readiness agencies, S2S provides students with real life laboratory problem-solving experiences led by scientific professionals using modern technology and instrumentation. S2S’s V-Laboratory educational program enlists corporate partners such as Alcami to serve as in-class mentors and help introduce students to the broad spectrum of STEM careers available to them.

Topics: Company News Alcami in Action

SCIENTIST SPOTLIGHT: April 2019

Name: Bhadresh Nayee
Alcami Site: Edison, NJ

How long have you been with Alcami?
I have been with Alcami since 2007.

What is your role? 
I’m working as a microbiology analyst at our Edison, New Jersey site. My day-to-day activities involve antibiotic testing, container closure integrity testing, and isolating/creating cultures of bacteria to study the impact of these microorganisms in order to obtain information on types and levels of microbial contamination.

What is the most rewarding part of your job?
The most rewarding part of my job is our clients' satisfaction from my work.

Topics: Alcami Voices